OCR — Lung Sound Monitor Class II
FDA product code OCR covers "Lung Sound Monitor", a Class II medical device regulated under 21 CFR 870.1875. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCR
- Device Class
- Class II
- Regulation Number
- 870.1875
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.